Integrating a Prescription Produce Program Within a Diabetes Prevention Program

September 8, 2026 updated by: Virginia Commonwealth University

Integrating a Prescription Produce Program Within a Diabetes Prevention Program to Address Health Inequities Among Adults

Type 2 Diabetes remains a major chronic disease among adults in the United States. A way to prevent Type 2 Diabetes is to engage in a diabetes prevention program. In the diabetes prevention program, individuals at risk of Type 2 Diabetes meet with a health coach to learn effective ways to build health behaviors around diet and physical activity. Individuals who participate in the diabetes prevention program are more likely to lose weight and eat a healthy diet.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The diabetes prevention program does not provide support for major factors influencing Type 2 diabetes, such as food insecurity or the challenge of accessing and eating healthy food to maintain optimal health. Millions of adults who are at risk of Type diabetes face challenges such as food insecurity and access to healthcare, transportation, and housing. A prescription produce program is a community-based initiative that supports an individual who may face food insecurity to access healthy fruits and vegetables and receive health advice and resources to manage their health, including referrals for health services, housing, and transportation. This research examines whether or not a diabetes prevention program integrating a prescription produce program provides more benefits in preventing Type 2 diabetes compared to a regular diabetes prevention program. Subjects in this study may lose weight, increase their knowledge of health, and provide additional services to manage their health.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Contact:
        • Principal Investigator:
          • Ana Diallo, PhD, MPH, BA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥age 18
  • rationale: adolescents who are at-risk of T2DM may have unique needs that will not be addressed in this study
  • Most recent BMI ≥ 25kg/m 2 and not pregnant
  • rationale: elevated BMI is associated with higher risk of developing T2DM
  • Elevated glucose as evidenced by one of the following criteria:
  • Hemoglobin A1c 5.7-6.4% indicative of prediabetes within the last 36 months
  • Fasting blood glucose 100-125mg/dl or 2-hour glucose 140-199mg/dl within the last six months
  • Physician diagnosis of prediabetes (impaired fasting glucose, impaired glucose intolerance)
  • These criteria indicate the presence of prediabetes and places individuals are risk of T2DM
  • Speak, read, and understand English
  • rationale: current version of PPP intervention (cooking classes) is available in English
  • Have a working U.S.- based phone number
  • rationale: participants must have a working phone number because they will receive automated text messages as reminders to receive session reminders; participants must have a working phone number in case adverse event monitoring contacts are required
  • Able to attend study-related sessions at the Health Hub @ 25th over the year long study (i.e., weekly for 4 months, then monthly for 7 months)
  • rationale: participants must be able to attend study activities at the community site in order to engage in the intervention and study related sessions.

Exclusion Criteria:

  • Individuals with HbA1c or glucose levels above the indicated glucose ranges will be advised to see their physician and excluded from participation unless they receive physician consent to participate.
  • Pregnant adults (>18 years old) will not be included in this current study because prediabetes (HbA1c levels between 5.7% - 6.4% within the last 36 months) during pregnancy presents unique physiological challenges that the study intervention does not address.
  • Pregnancy status will be based on participants self-report. We will not provide any pregnancy tests prior to enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prescription Produce Program (PPP) within a Diabetes Prevention Program (DPP)
The research intervention in this study is the DPP + Produce Prescription Plan (DPP+PPP). Besides receiving the DPP, the intervention group participants will receive bags of fresh fruits and vegetables, attend four cooking demonstrations, and if there are positive screens for social needs, be referred to work with a community-based wellness program to access resources.
Behavioral: Diabetes Prevention Program (DPP)
A 12-month lifestyle change program incorporating the latest evidence on self-efficacy, physical activity, and healthy diet.
Behavioral: Produce Prescription Plan (PPP)
The research intervention in this study is the DPP + Produce Prescription Plan (DPP+PPP). Besides receiving the DPP, the intervention group participants will receive bags of fresh fruits and vegetables, attend four cooking demonstrations, and if there are positive screens for social needs, be referred to work with a community-based wellness program to access resources.
Placebo Comparator: Diabetes Prevention Program (DPP) only
All participants in this research study will participate in the Diabetes Prevention Program (DPP), which is a 12-month lifestyle change program incorporating the latest evidence on self-efficacy, physical activity, and healthy diet. Additionally, all participants will be screened for social needs at regular timepoints and receive a list of available resources.
Behavioral: Diabetes Prevention Program (DPP)
A 12-month lifestyle change program incorporating the latest evidence on self-efficacy, physical activity, and healthy diet.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of recruitment rates
Time Frame: Baseline, 16 weeks, 6 months, and 12 months
Assess feasibility and acceptability by recording and measuring the recruitment rates.
Baseline, 16 weeks, 6 months, and 12 months
Assessment of enrollment rates
Time Frame: Baseline, 16 weeks, 6 months, and 12 months
Assess feasibility and acceptability by recording and measuring the enrollment rates.
Baseline, 16 weeks, 6 months, and 12 months
Assessment of attendance
Time Frame: Baseline, 16 weeks, 6 months, and 12 months
Assess feasibility and acceptability by recording and measuring the attendance rates.
Baseline, 16 weeks, 6 months, and 12 months
Assessment of retention rates
Time Frame: Baseline, 16 weeks, 6 months, and 12 months
Assess feasibility and acceptability by recording and measuring the retention rates.
Baseline, 16 weeks, 6 months, and 12 months
Assessment of blood glucose
Time Frame: Baseline, 16 weeks, 6 months, and 12 months
Blood glucose (hemoglobin A1c) will be recorded and measured to asses the blood glucose levels.
Baseline, 16 weeks, 6 months, and 12 months
Assessment of weight
Time Frame: Baseline, weekly for the first 16 weeks, them monthly from 5 to 12 months
Weight will be will be recorded and measured for assessment
Baseline, weekly for the first 16 weeks, them monthly from 5 to 12 months
Minutes of physical activity
Time Frame: weekly for the first 16 weeks, them monthly from month 5 to 12.
average amount (in minutes) of physical activity completed
weekly for the first 16 weeks, them monthly from month 5 to 12.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of food security needs
Time Frame: Baseline, 16 weeks, 6 months, and 12 months
Using the Brief Social Needs evaluation to assess the participants food security needs using the Brief social needs including 2-item food security .
Baseline, 16 weeks, 6 months, and 12 months
Assessment of social needs
Time Frame: Baseline, 16 weeks, 6 months, and 12 months
Using the American Academic of Family Physician Social Needs Screening form to assess the participants social needs. This assessment is a set of validated questions designed to help healthcare providers identify and address social determinants of health. Underlined answers generally indicate a positive response for a social need. For the Personal Safety section, a total numerical value greater than 10 indicates a positive screen.
Baseline, 16 weeks, 6 months, and 12 months
Assessment of diet quality
Time Frame: Baseline, 16 weeks, 6 months, and 12 months
Using the Healthy Eating Index derived from DietID™,an assessment tool capturing dietary intake through innovative Diet Quality Photo Navigation (DQPN®) to assess the participants diet quality. The Diet ID scoring system provides a diet quality score on a 1-10 scale. A Diet ID score of 10 represents the highest quality (HEI 90-100), while a score of 1 represents the lowest.
Baseline, 16 weeks, 6 months, and 12 months
Assessment of medication adherence
Time Frame: Baseline, 16 weeks, 6 months, and 12 months
Medication adherence will be recorded and measured for assessment
Baseline, 16 weeks, 6 months, and 12 months
Assessment of wellness goals set and met
Time Frame: Baseline, 16 weeks, 6 months, and 12 months
Wellness goals set and met will be recorded and measured for assessment
Baseline, 16 weeks, 6 months, and 12 months
Assessment of physical activity
Time Frame: Baseline, 16 weeks, 6 months, and 12 months
Physical activity will be recorded and measured for assessment using International Physical Activity Questionnaire (IPAQ) measures time spent sitting, light, moderate, and vigorous activity over a set period (e.g., past 7 days), increased activity time at a higher rate of activity will indicate increased physical activity.
Baseline, 16 weeks, 6 months, and 12 months
Assessment of Blood pressure
Time Frame: Baseline, 16 weeks, 6 months, and 12 months
Both systolic and diastolic blood pressure will be recorded and measured for assessment.
Baseline, 16 weeks, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Commonwealth University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ana Diallo, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HM300000239
  • R01DK142965 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings